Methods for toposcopic sleeve delivery

ABSTRACT

Disclosed herein are elongate flexible medical devices which are capable of axial elongation through the mechanism of eversion or toposcopic expansion. In general, this may be accomplished by providing a flexible tubular device having a proximal end and a distal end. Retraction of the distal end in a proximal direction through the tubular body inverts the tube upon itself, causing an axial shortening of the overall length of the device. The original length of the device can be restored by coupling a pressurized media to the proximal end of the sleeve. If the distal end of the sleeve is temporarily restricted or closed, the pressurized media causes the distal end of the sleeve to travel distally until the full length of the sleeve has been restored.

This application claims priority under 35 U.S.C. §120 as a continuationof U.S. patent application Ser. No. 11/861,172 filed Sep. 25, 2007,which in turn claims priority under 35 U.S.C. §119(e) as anonprovisional of U.S. Provisional Application No. 60/826,862 filed Sep.25, 2006. Each of the aforementioned priority applications is herebyincorporated by reference in their entireties.

U.S. patent application Ser. No. 10/698,148, filed Oct. 31, 2003,published May 13, 2004 as U.S. Patent Pub. No. 2004-0092892 A1 andentitled “APPARATUS AND METHODS FOR TREATMENT OF MORBID OBESITY” (andmay be referred to herein as the “Kagan '148 Application”); U.S. patentapplication Ser. No. 11/025,364, filed Dec. 29, 2004, published Aug. 11,2005 as U.S. Patent Pub. No. 2005-0177181 A1 and entitled “DEVICES ANDMETHODS FOR TREATING MORBID OBESITY” (and may be referred to herein asthe “Kagan '181 Application”); U.S. patent application Ser. No.11/124,634, filed May 5, 2005, published Jan. 26, 2006 as U.S. PatentPub. No. 2006-0020247 A1 and entitled “DEVICES AND METHODS FORATTACHMENT OF AN ENDOLUMENAL GASTROINTESTINAL IMPLANT” (and may bereferred to herein as the “Kagan '634 Application”); U.S. patentapplication Ser. No. 11/400,724, filed Apr. 7, 2006, published Jan. 11,2007 as U.S. Patent Pub. No. 2007-0010794 A1 and entitled “DEVICES ANDMETHODS FOR ENDOLUMENAL GASTROINTESTINAL BYPASS” (and may be referred toherein as the “Dann '724 Application”); and U.S. patent application Ser.No. 11/548,605, filed Oct. 11, 2006, entitled “DEVICES AND METHODS FORENDOLUMENAL GASTROINTESTINAL BYPASS” (and may be referred to herein asthe “Dann '605 Application”) are hereby incorporated by reference intheir entireties herein, as well as any additional applications,patents, or publications noted in the specification below.

BACKGROUND OF THE INVENTION

A wide variety of medical procedures involve the introduction ofcatheters, endoscopes, and other devices through natural lumen andartificially created passageways in the body. Certain applicationsrequire creating a device path through a sphincter or narrow body lumen,or through a long, tortuous pathway. Conventional distal axial advance(i.e., pushing) of a device is sometimes unable to reach a desiredtreatment or diagnostic site, and may in any event cause discomfort tothe patient or trauma to delicate or sensitive tissues as the device isbeing advanced.

Lubricants and lubricious polymers or other coatings can reduce theseeffects, but not always to a sufficient degree. In the biliary system,as one example, passing a biliary catheter through the ampulla of Vaterand into the common bile duct often results in swelling and subsequentclosure of the opening, compromising normal drainage and makingsubsequent access difficult. Similar problems with discomfort or edemaor failure to achieve proper device placement can be experienced by thepatients when other anatomical sites are being accessed, for example, inthe nasal passages, urethra, small intestine, colon, rectum, etc. Whilepatient comfort may not be an issue when navigating internally such aswithin the biliary tree, the introduced device may be difficult or evenimpossible to advance as a result of frictional forces acting againstit, especially since these obstructions and narrowed passages oftencannot be adequately visualized.

Besides the biliary system, a variety of other sites within the bodypresent an opportunity for improved access, patient comfort and reducedtrauma during the introduction of a device. For example, the nasalpassages are especially sensitive and recent trends have brought aboutan increase in the number of devices, such as endoscopes and tubes,being introduced via that route concomitant with the use of analgesicsor sedatives to reduce patient discomfort.

Another setting where improved access would be important is for any of avariety of diagnostic or therapeutic procedures in the lowergastrointestinal tract. Accessing the small intestines is a significantchallenge with current endoscopic technologies. The intestines aresubstantially unconstrained, mobile and follow a tortuous path so it isdifficult to advance a pushable device through the intestinal lumen.Using an enteroscope to access the intestines can often provide accessto the proximal region and the newer double balloon enteroscopes canaccess more distally by using the two balloons to push and pull againstthe wall of the intestines. However, both methods rely on applying apushing force on the device or using the device to apply force againstthe walls of the intestine to advance the devices. Using a device asdescribed herein would enable deployment of a device throughout thesmall intestine with less force acting on the intestine. The device asdescribed could be used as a guide conduit for advancing an enteroscopeor other device or it could deploy a guide wire or deliver therapeuticor diagnostic devices to affect treatment of the small intestine.

Therefore, what is needed is a medical device introducer system that canbe incorporated into or used with a variety of catheter(s), sheath(s),endoscope(s) or other medical devices to permit the safe and comfortablepassageway into and/or through a bodily passage to a remote proceduresite.

SUMMARY OF THE INVENTION

In one embodiment, disclosed is a toposcopic deployment system thatincludes a filling catheter, a sleeve configured to be delivered withina body lumen, and a grasping member configured to be attached to thesleeve and mechanically promote eversion of the sleeve. The sleeve is atleast partially inverted within the filling catheter. In someembodiments, the system includes a pump for infusing inflation media tothe filling catheter. The system can also include a source of fillingmedia. The grasping member may include a loop snare. The sleeve mayinclude a plurality of tail elements, such as, for example, three tailelements spaced substantially equidistant with respect to thecircumference of a lumen of the sleeve. The filling catheter may be apushable tube. The filling catheter may be collapsible in someembodiments, or alternatively semi-rigid. The delivery system mayinclude at least one pull wire operably attached to the filling catheterto steer the filling catheter within a body lumen. The system mayinclude, in some embodiments, a guidewire and/or an overtube. The sleevemay be biodegradable. The system may also include a diagnostic ortherapeutic device operably connected to the sleeve selected from thegroup consisting of: endoscopes, guidewires, catheters, tubular bypassconduits, drugs, adhesives, radiopaque contrast media, cameras, lasers,ultrasound transducers, electrodes, LEDs, cryogenic energy sources,balloons, forceps, graspers, electrosurgical instruments, snares, biopsydevices, needles, guidewires and rail systems.

In another embodiment, also disclosed herein is a method oftoposcopically delivering a sleeve to a body lumen, according to someembodiments of the invention. The method includes the steps of providingthe sleeve at least partially inverted within a filling catheter, thesleeve comprising a proximal end, a distal end, and an elongate body,the proximal end of the sleeve attached to a distal end of the fillingcatheter; advancing the sleeve and the filling catheter to position thedistal end of the filling catheter at a first point in the body lumen;and flowing inflation media within the sleeve to promote eversion of thesleeve to a second point in the body lumen. The body lumen can be thegastrointestinal tract. The method can also include the step of at leastpartially inverting the sleeve within the filling catheter. In someembodiments, the method also includes the step of sealing the distal endof the sleeve. Sealing the distal end of the sleeve may includeattaching a grasping member to the distal end of the inverted sleeve.The method may also include the step of actuating the grasping memberdistally to promote eversion of the sleeve. The grasping member can be aloop snare. In some embodiments, the distal end of the inverted sleeveincludes a plurality of tail elements. In some embodiments, flowing theinflation media within the sleeve to evert the sleeve is accomplished ata pressure of less than about 3 psi. In some embodiments, the methodfurther includes steering the filling catheter within the body lumenusing one or more pull wires operably attached to the filling catheter.

In some embodiments, also disclosed herein is a method of delivering asleeve to a body lumen, including the steps of providing a sleeveconfigured to be delivered within a body lumen, the sleeve having anaxially compressed configuration for delivery to a body lumen and anaxially elongate configuration after the sleeve is delivered, wherein atleast a portion of the sleeve has accordion-like features; operablyconnecting the sleeve to a filling catheter in the sleeve's axiallycompressed configuration; and flowing inflation media within the sleeveto promote transformation of the sleeve from the axially compressedconfiguration to an axially elongate configuration.

In some embodiments, disclosed is a toposcopic delivery system includinga filling catheter and a sleeve configured to be delivered within a bodylumen, the sleeve having an axially compressed configuration fordelivery to a body lumen and an axially elongate configuration after thesleeve is delivered. The length of the sleeve in its axially elongateconfiguration can be at least about 100% longer than a length of thesleeve in its axially compressed configuration. In some embodiments, thesleeve includes a portion with accordion-like features.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic cross-sectional view of a toposcopic sleevepartially inverted within itself.

FIG. 1B is a schematic illustration as in FIG. 1A, with the toposcopicsleeve fully distally extended.

FIG. 1C is a schematic illustration of a sleeve with a plurality ofdistal elongate tail elements.

FIG. 2A is a schematic illustration as in FIG. 1A, with the toposcopicsleeve more fully inverted within itself.

FIG. 2B is a schematic illustration as in FIG. 2A, with a doubleinversion of the toposcopic sleeve.

FIG. 2C is a schematic illustration of a sleeve with accordion-likefeatures that can be axially expanded.

FIG. 2D is a schematic illustration as in FIG. 2C, where the sleeve ispartially axially expanded.

FIG. 2E is a schematic illustration as in FIG. 2D, where the sleeve iscompletely axially expanded.

FIG. 3A is a schematic illustration of a filling tube extending throughthe stomach to the pylorus, having a toposcopically deliverable sleeveproximally retracted therein.

FIG. 3B is a schematic view as in FIG. 3A, with the sleeve partiallyeverted into the intestine.

FIG. 3C is a schematic illustration as in FIG. 3B, with the toposcopicsleeve fully deployed within the intestine.

FIG. 4 is a schematic representation of a toposcopic deployment systemin accordance with the present invention.

FIG. 5 is a detail view of the distal end of the system illustrated inFIG. 4.

FIGS. 6A and 6B are additional detail views of a toposcopic deploymentsystem.

FIG. 6C is a schematic cross sectional view illustrating the availablespace within an over tube, for an endoscope and a toposcopic deploymentsystem.

FIG. 7A is a cross sectional view through an over tube, illustrating anendoscope and a collapsible filling catheter.

FIG. 7B is a side perspective view of an endoscope, having a collapsiblefilling catheter attached thereto.

FIG. 7C is an alternate view of an endoscope having a collapsiblefilling catheter attached thereto.

FIG. 8 is a cross sectional view as in FIG. 7A, with a fixed crosssectional configuration filling catheter.

FIG. 9 is a schematic illustration of an endoscope carrying acollapsible filling catheter to a position in the vicinity of thepylorus.

FIG. 10 is a schematic illustration of an alternate method of advancinga collapsible filling catheter to the vicinity of the pylorus.

FIGS. 11A and 11B illustrate a steerable filling catheter, with a distalend positioned in the vicinity of the pylorus.

FIGS. 12A and 12B illustrate a toposcopic delivery system in accordancewith the present invention, for delivering a guidewire or other deviceto a remote treatment site.

FIG. 13A-13D schematically illustrate an alternative toposcopicguidewire delivery system in accordance with the present invention.

FIG. 13E schematically illustrates a sleeve being deployed into thecommon bile duct, according to one embodiment of the invention.

FIG. 14A is a top view of a loop snare that can be utilized duringtoposcopic delivery, according to one embodiment of the invention.

FIG. 14B is a side view of the loop snare in FIG. 14A, betterillustrating the proximal portion of the snare.

FIG. 14C schematically illustrates another embodiment of a loop snare,according to one embodiment of the invention.

FIGS. 14D-14F depict a method of creating a seal at the distal end of asleeve by sequentially folding down a plurality of distal tail elementsusing a loop snare, according to one embodiment of the invention.

FIGS. 14G-14H illustrate another method of creating a seal at the distalend of a sleeve using the elements shown in FIGS. 14D-14F.

FIGS. 15A-15G schematically illustrate a sleeve being inverted withininto a toposcopic delivery system using a grasping element, according toone embodiment of the invention.

FIG. 15H schematically illustrates a filling catheter and sleeve kit,according to one embodiment of the invention.

FIGS. 16A-16B illustrate a toposcopic delivery system including a snarein accordance with the present invention, for delivering a sleeve to aremote treatment site.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to elongate flexible medical devices whichare capable of axial elongation through the mechanism of eversion ortoposcopic expansion. In general, this may be accomplished by providinga flexible tubular device having a proximal end and a distal end.Retraction of the distal end in a proximal direction through the tubularbody inverts the tube upon itself, causing an axial shortening of theoverall length of the device. The original length of the device can berestored by coupling a pressurized media to the proximal end of thesleeve. If the distal end of the sleeve is temporarily restricted orclosed, the pressurized media causes the distal end of the sleeve totravel distally until the full length of the sleeve has been restored.The general topic of toposcopic deployment is understood in the art.

In general, the toposcopic devices in accordance with the presentinvention may be utilized for any of a variety of purposes, some ofwhich are exemplified below. For example, the toposcopic sleeve may beutilized as a conduit for enabling the introduction of any of a varietyof diagnostic or therapeutic devices. These include endoscopes,guidewires, catheters, tubular bypass conduits, drugs, adhesives,radiopaque contrast media, cameras, lasers, ultrasound transducers,electrodes, LEDs or other light sources, cryogenic energy sources,balloons, forceps, graspers, electrosurgical instruments, snares, biopsydevices, needles, guidewires and rail or other guidance systems forguiding additional instrumentation.

In one embodiment of the current invention, a delivery device is used toadvance the distal end of an inverted sleeve to a desired deploymentsite in a lumen. The delivery device may be a pushable filling catheteritself or a secondary device that is used to advance a non-pushablefilling catheter. Examples of a separate delivery device used to advancethe distal end of the inverted sleeve include a pediatric colonoscope,enteroscope, endoscope, duodenoscope, or a simple pushable rod orcatheter that can be attached to the filling catheter. Once at thedesired deployment site, for example, past the pylorus, a fluid, eithercompressible or non-compressible, is delivered into the filling catheterto deploy the toposcopic element. U.S. Application 2001/0044595A1 filedMay 2, 2001, entitled Introducer Apparatus with Eversible Sleeve, thedisclosure of which is incorporated in its entirety herein by reference,describes a pushable catheter with an everting distal end used to accessthe small intestines, however in this device the medium that is advancedto deploy the everting section is a solid inner member.

In addition, although the toposcopic sleeve will be disclosed belowprimarily in the context of a gastrointestinal access device orgastrointestinal implant, devices in accordance with the presentinvention may be utilized to access any of a wide variety of naturallumen, hollow organs, or artificially created tissue tracts throughoutthe body. The length, diameter, wall thicknesses, construction of thefilling tube and other features disclosed below may be modified to suitthe intended target or access pathway as will be apparent by those ofskill in the art in view of the disclosure herein.

For example, in the gastrointestinal system, the toposcopic sleeve maybe utilized to access the esophagus, lower esophagus, gastroesophagealjunction, stomach, the pylorus, biliary ducts, the gallbladder, thesmall intestine, the appendix, the caecum, the large intestine, theanus, or other locations in between. Toposcopic devices in accordancewith the present invention may also be utilized throughout thecardiovascular system, as well as the airways including the trachea andbronchial tree.

From a procedure standpoint, the toposcopic sleeves of the presentinvention may be utilized to deliver devices or otherwise assist withERCP, nasal gastric tube delivery, diagnosis and treatment of intestinalbleeding, using electro coagulation or other technique, treating ulcers,remove polyps, intestinal biopsy, stent deployment, dilatation ofstrictures, tagging or marking areas for subsequent surgeries such astreatment sites within the intestine, creating a sterile conduit foraccessing a treatment site, any of a wide variety of endoscopic andtransgastric procedures, stomach pumping, tracheostomy tube delivery andbronchoscopy. Potential procedures also include biopsy of any of avariety of organs such as liver biopsy, removal of any of a variety oforgans or tumors such as appendectomy, and localized delivery ofpharmaceutical agents or biologically active agents to a treatment site.

In addition to utilizing the everting tubes of the present invention toaccess a wide variety of sites to accomplish any of a variety ofprocedures, the toposcopic delivery sleeve may also be utilized as atransport vehicle to carry wires or secondary devices to the treatmentsite. This may be accomplished by attaching the distal end of the tubeto a device or guide, and everting the tube thereby carrying the deviceor guide in a distal direction for placement in the patient. Any of awide variety of diagnostic or therapeutic devices may be carried to aremote site, such as radiofrequency diagnostic or therapeutic devices,diagnostic or therapeutic ultrasound, EM, piezoelectric pressuresensors, micro fluidic sensors, endoscopes, such as capsule endoscopes,and the like. The everting tube may also be utilized to deliverguidewires, catheters, tethers, rail systems or NG tubes to the desiredsite or the everting tube itself may serve as a guide conduit orovertube for other devices. In the example of a guidewire, the wirecould be delivered using one of the following examples. The guidewirecan be attached to the distal end of the tube and reside in the deliverycatheter before the everting tube is deployed. In this method, theeverting process pulls the guidewire distally as the sleeve everts. Inanother embodiment, the wire can reside along the outer surface of theeverting tube before deployment, the wire making a 180° bend around theinverted radius of the sleeve and being attached or placed at or nearthe distal end of the sleeve. In this way it is always along what willbe the outer diameter of the sleeve after deployment. The more proximalsection of the guidewire in this embodiment could be held by a lumenalongside the OD of the filling catheter or a series of eyelets orclasps. In this method, as the sleeve is deployed the distal radius ofthe sleeve as it transitions form inverted to everted lays the guidewiredown between the sleeve and the body lumen in which it is beingdeployed. Once fully everted the guidewire would be deployed alongsidethe delivery device. If desired, the delivery device could then bere-inverted by a retrieval wire (or grasping element, such as a snare,described in more detail below) in the central lumen of the deliverydevice attached to the distal end of the everting section. Re-invertingof the delivery device would leave the guidewire in place and thefilling catheter could be pulled out of the lumen over the wire. Partialre-inverting could also be utilized to expose various locations of thesmall intestine as needed during a procedure to enable bettervisualization with a scope, tissue biopsy, ablation, coagulation, drugdelivery or whatever a procedure may require.

Certain exemplary applications of the present invention will bedescribed below. Modifications to accomplish any of the precedingapplications may be made by those of skill in the art in view of thedisclosure herein.

In one implementation of the invention, an endolumenal bypass sleeve maybe deployed within the intestine using a toposcopic, or evertingtechnique. Additional details are disclosed in U.S. patent applicationSer. No. 11/400,724 entitled Devices and Methods for EndolumenalGastrointestinal Bypass, filed Apr. 7, 2006, the disclosure of which isincorporated herein in it entirety by reference. Pressurization may beaccomplished by placing the proximal end of the axially inverted sleevein communication with a source of inflation or everting media, such as aliquid or gas. Liquid such as water or saline may be preferred, and mayadditionally be provided with a radiopaque additive to permit real timefluoroscopic visualization of the progress of the deployment within theGI system. The use of lubricants is discussed below. Additionaladditives may also be provided, such as antibiotics, nutritionalsupplements or others as may be desired.

To maintain the internal fluid pressure used to assist in everting theinverted gastrointestinal sleeve, the distal end of the sleeve may betemporarily occluded or sealed during deployment. FIGS. 1A-1B illustrateone of a number of options for sealing the distal end 112 of agastrointestinal sleeve 100 during delivery and deployment. FIG. 1Ashows the distal end 112 of the gastrointestinal sleeve 100 invertedwithin the sleeve 100 and retracted a short distance in the proximaldirection. The otherwise open distal end 112 is shown sealed with asuture or tie 150 which may be degradable and formulated to dissolvewithin a desired time such as no more than approximately 2 or 6 or 24hours following deployment in the intestines. Dissolution of thebiodegradable tie 150 can be aided by introduction of a solvent, oractive agent, or inducing a pH change that is ingested or placed in theeverting fluid. The distal end 112 may also be releasably secured to apull line 152 such as a suture or wire, or a grasping member such as asnare, to assist in inverting the sleeve as will be apparent to those ofskill in the art. Alternatively, the suture, wire, or grasper could bedelivered by the sleeve and act as a guide wire for the placement of anyof a number of other devices in the GI tract. FIG. 1B shows thenoninverted (everted, or deployed) distal end 112 of thegastrointestinal sleeve 100 sealed with a biodegradable tie 150 that maybe formulated to dissolve within the intestines.

FIG. 1C illustrates an embodiment of a sleeve 100 with a plurality ofelongate projections 801 (also referred to herein as tails) herein thatcan extend distally past the distal opening 112 of the sleeve 100. Thetails 801 have a proximal end 802, an elongate body 803, and a distalend 804. The tails 801 can be integrally formed with the rest of thesleeve 100, or alternatively operably attached to the sleeve 100 byadhesive, bonding, annealing, suturing, or the like. The elongate tails801 can advantageously be secured together at their distal ends 804 asshown below in FIGS. 14D-14F, such as with a tie, adhesive, or agrasping device, such as a snare (as will be described below). The tails801 are preferably spaced substantially equally apart with respect tothe circumference of the distal opening 112 of the sleeve 100, and sizedto provide a consistent fluid-tight or near fluid-tight seal of thedistal end 112 of the sleeve 100 as well as to promote substantiallysymmetric and predictable inversion and eversion of the sleeve 100 usinginflation media. In one embodiment, the sleeve 100 includes 3 tailelements 801 spaced approximately 120 degrees apart with respect to thecircumference of the distal opening 112 of the sleeve 100. In otherembodiments, the sleeve 100 includes 2, 4, 5, 6, 7, 8, or more tails. Insome embodiments, such as for a sleeve deployed into the intestine, thetails 801 are at least about 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 10 cm,or longer in length, and have a width of no more than about 1 cm, 2 cm,or 3 cm.

The distal end 112 of a sleeve may alternatively be temporarily occludedusing adhesives, such as a water soluble adhesive or pressure sensitiveadhesive applied to the interior surface of the distal end 112 of thesleeve. Alternatively, the distal end of the sleeve may be collapsed andfolded over onto itself with or without the use of adhesives. Solventbonding, thermal spot welding or other bonding technique may be used toclose the distal end 112, in a manner that a slight increase in pressurecan be applied to the inflation media following full deployment, torupture the seal. A tie line may alternatively extend proximally fromthe distal end 112, either inside of the lumen or outside of the sleeve100. Proximal retraction of the tie line following sleeve placement willuntie a knot or otherwise release the distal end 112. Otherwise thedistal end may be simply left open during the deployment process.Alternatively, the tie line may not release the end of the sleeve butcould act as a retrieval line for re-inverting the sleeve back into thefilling catheter if so desired.

FIG. 2A shows a gastrointestinal sleeve 100 retracted proximally insideof itself in an inverted configuration. FIG. 2B shows a gastrointestinalsleeve 100 loaded in a double-inverted configuration. A full singleinversion will reduce the length of the sleeve 100 by at least about50%, while a full double inversion will reduce the length of the sleeve100 to no more than about 25% of its original length. The sleeve can beinverted up to 100% with a single inversion by pulling the distal end112 proximally of the proximal end of the sleeve, such as into a fillingtube or other placement device.

Deployment of the sleeve may be accomplished by positioning the distalend 154 of the inverted sleeve 100 at a first position within the targetlumen such as the GI tract, and then second everting the sleeve toposition the everted distal end at a second position within the GItract, downstream (from a device deployment perspective) from the firstposition. The second position will normally be at least about 50 cm andoften at least about 75 cm or 100 cm or more distally of the pylorus.The second position could potentially be to anywhere in the smallintestine, to the mecum, to the colon, or even all the way through theGI tract and out the anus. The first position where the distal end 154of the inverted sleeve is placed may be at about the pylorus, withinabout 20 cm of the pylorus, or within about 50 cm of the pylorus,depending upon the device design and desired deployment procedure.

Inverting the sleeve simplifies the delivery and deployment of thedevice, but it adds some additional constraints to the configuration ofthe device. The inverting segments can have very thin walls andinverting interfaces can be highly lubricious for easy and reliabledeployment. For example, blow molded 90A durometer polyurethane of awall thickness on the order of 0.005″ or less, preferably about 0.002″,with a lubricious coating may work in this manner. Another example of asuitable material is PTFE. Eversion within the intestine may beaccompanied by introduction of an irrigating or lubricating fluid on theoutside of the sleeve 100, and/or provision of a lubricant in betweencontacting surfaces of the inverted sleeve. Additional details aredisclosed in co-pending application Ser. No. 10/698,148, filed Oct. 31,2003, entitled Apparatus and Methods for Treatment of Morbid Obesity,the disclosure of which is incorporated in its entirety herein byreference.

FIGS. 2C-2E illustrates an embodiment of a sleeve 101 that does notrequire inversion prior to delivery within the body lumen. The sleeve101 is shown operably attached at its proximal end 103 and forming afluid-tight seal 468 with filling catheter 400, as described furtherbelow. The sleeve 101 shown is configured to form an axially compressedshape, such as having an accordion-like portion 103 for delivery,transforming into an axially elongated configuration after delivery, asshown in FIG. 2E. FIG. 2D illustrates an intermediate configurationwhere the sleeve 101 is in process of elongating to the axiallyelongated configuration. In some embodiments, the sleeve 101 may bepleated to form a bellows-like device. The sleeve 101 may be made of anyappropriate material, although we have discovered that PTFE (TEFLON®) isespecially well-suited for axially compressing the sleeve 101 in anaccordion-like fashion.

The sleeve 101 can be transformed from an axially compressedconfiguration to an axially elongated configuration by flowing inflationmedia through the lumen of the sleeve 101 as disclosed above. The sleevecan also be transformed using a grasping tool, such as a snare, toprovide a mechanical force to promote transformation and decrease thepressure and/or volume of inflation media required, as will be discussedbelow.

The distal end 112 of the sleeve 101 may be temporarily occluded orsealed during deployment to facilitate the pressure gradient sufficientto allow sleeve 101 to axially expand. In one embodiment, fillingcatheter 400 passes into the lumen of sleeve 101 and a fluid-tight seal468 is created between the proximal end of sleeve 101 and the distal endof filling catheter 400, as shown. Tubing 470 can be utilized to providea passageway between filling catheter 400 and device 416. In someembodiments, a temporary barrier can be created at distal end 112 ofsleeve 101. The temporary barrier may be created by collapse of distalend 112 caused by the influx of fluid through filling catheter 400. Inother embodiments, distal end 112 can be blocked with an absorbable ordegradable plug comprising cellulose, sugar-based substances, PLA, aswell as other techniques discussed elsewhere herein. Distal end 112 mayalso be closed with a grasping member such as a loop snare discussedelsewhere herein.

In some embodiments, the sleeve with an accordion-like portion as shownin FIGS. 2C-E can be expanded axially by at least about 50%, 75%, 100%,125%, 150%, 200%, 250%, 300%, 400% or more of its axially compressedlength. In some embodiments, the sleeve can be both inverted and axiallycompressed.

In some embodiments, the sleeve may include one or more elements thatcan be configured to be biased such that eversion of the sleeve ispromoted. For example, the sleeve may have one or more embedded elementswithin or proximate to the wall of the sleeve with a spring force (e.g.,a metal, such as a nitinol ribbon) biased to facilitate eversion.

FIG. 3A shows an elongate, flexible filling catheter 400transesophageally positioned such that it extends across the length ofthe stomach and its distal end 402 is about at the pylorus 116, oralternatively past the pylorus 116. The proximal end of sleeve 100 isattached to the distal end of filling catheter 400, and the distal end112 of sleeve 100 retracted proximally within the filling catheter 400at least as far as the esophagus 164 to fully invert the sleeve 100within the filling catheter 100.

As used herein, the term “filling catheter” is intended to refer to anyof a wide variety of structures which are capable of placing anevertable sleeve 100 in communication with a source of inflation media.In general, the filling catheter will include at least one lumen forconveying inflation media. In the illustrated embodiment, the centrallumen of the filling catheter 400 is also utilized to receive theproximally retracted distal end 112 of the sleeve 100.

The filling catheter may exhibit sufficient column strength to enabledistal advance of the distal end 402 to the desired site where eversionis to commence. Alternatively, collapsible filling catheters may becarried into position by a secondary instrument such as an endoscope, asis discussed below. The filling catheter may be a single lumen tube, asschematically illustrated in FIG. 3A, or a multi-lumen structure as willbe apparent to those of skill in the art in view of the disclosureherein. To simplify the discussion herein, the filling catheter 400 willprimarily be illustrated in its simplest form as an elongate flexiblesingle lumen tubular body.

FIG. 3B shows sleeve 100 partially deployed such that distal end 112 hasadvanced past GEJ 106. As the sleeve 100 is deployed under the influenceof an everting force, a leading fold or distal end 154 continuallyadvances down the intestine until the sleeve 100 has been fullydeployed. At that point, the leading fold 154 disappears, and distal end112 of the sleeve 100 everts from the interior of the sleeve 100 to itsfinal, fully extended configuration. See FIG. 3C.

The device utilized to illustrate the sequence of FIGS. 3A through 3C issimplified in a variety of ways. For example, the distal end 402 of thefilling catheter 400 is positioned at about, or at any point past thepylorus. The distal end 402 of the filling catheter 400 may bepositioned at any of a variety of locations along the desired accesspathway, taking into account the desired guidance to be provided to thesleeve 100 to enable it to reach its final fully deployed site. Thus,the distal end 402 may in an antegrade approach to a gastrointestinalaccess be positioned at least as far as the pylorus, to avoid improperdeployment of the sleeve 100 within the stomach. However, depending upondevice design, the distal end 402 may be advanced further downstreamwithin the intestinal tract.

The proximal end of sleeve 100 is illustrated as being attached to thefilling catheter 400 at its distal end 402. However, the sleeve 100 maybe attached to the filling catheter at any of a variety of otherlocations, such as proximally of the distal end, depending upon thedesired location of the finished assembly. For example, the proximal endof the sleeve 100 may be spaced apart from the distal end 402 of thefilling catheter 400 by an overlap distance such at least about 5 cm,sometimes at least about 10 cm, or otherwise, depending upon therelationship between the desired attachment site, if any, between theproximal end of the sleeve 100 and the anatomy relative to the desiredlocation of the distal end 402 of filling catheter 400 for the purposesof deployment.

In general, the filling catheter 400 performs at least two functions inthe context of the present invention. Once function is to place thesleeve 100 in communication with a motive force which will operate todistally deploy the sleeve 100. Although generally described herein asan inflation media such as a liquid or a gas, the deployment force couldalso be provided by an elongate flexible push rod, which can be distallyadvanced through the central lumen to cause toposcopic deployment of thesleeve 100.

In addition, the filling catheter 400 serves the purpose of positioningthe proximal end of the sleeve 100 at a predetermined point within theanatomy, from which toposcopic deployment will commence. Thus, thedevices disclosed herein generally provide two end-to-end modes ofaccess to a remote site. A first mode of access if provided from thenatural or artificially created opening on the surface of the patientalong an access pathway to the distal end 402 of the filling catheter400. This mode of access generally involves conventional distal axialadvance of a tubular member, relying either upon its own columnstrength, or the column strength provided by an associated device. Oncethe distal end 402 is in position at the desired launch point, thesecond mode of access is provided by distally deploying the toposcopicsleeve 100. The length of the filling catheter 400 may be variedconsiderably, depending upon the desired placement site for the distalend 402. In general, lengths of at least about 10 cm, often at leastabout 25 cm, and in some embodiments, at least about 50 cm, 60 cm, 75cm, 100 cm, 125 cm, 150 cm, or more may be used.

In the case of particularly tortuous anatomy, more than one toposcopicdelivery sleeves in accordance with the present invention may beutilized in series. For example, a first filling catheter may bepositioned along a first length of an access pathway. The toposcopicsleeve 100 may then be deployed along a second segment of the accesspathway. A second toposcopic delivery system may thereafter be coaxiallydistally advanced through the first filling catheter and firsttoposcopic sleeve. A second toposcopic sleeve may thereafter be deployedsuch that it extends beyond the distal end of the first toposcopicsleeve. In this manner, an access pathway comprising two or three ormore coaxially aligned toposcopic sleeves 100 may be utilized.

As shown in FIG. 4, filling catheter 400 is placed in fluidcommunication with a device 416 that infuses filling catheter 400 withinflation media such as a fluid. Device 416 can comprise, for example,an electronic or hand-actuated piston or plunger, hand pump, impellerpump, or peristaltic pump. In some embodiments, an endoscope can flushfilling catheter 400 with fluid. Device 416 can in turn be placed influid communication with a fluid source 420. For example, device 416 canbe in fluid communication with a container 420 that holds fluid.Container 420 can hold volumes of fluid ranging from 0.25 liters to 15liters or more, depending upon the desired functionality. In certain GIembodiments, container 420 holds between about one and about fiveliters. Device 420 can flush fluid through filling catheter 400 at arate ranging from about 5 cc to about 100 cc per stroke or actuation ofdevice 420. In some embodiments, device 420 flushes fluid throughfilling catheter 400 at a rate of from about 30 cc to about 300 cc perstroke.

Optionally, the filling catheter 400 or the device 416 can have apressure or volume measurement device to measure the pressure ordelivered volume of fluid that is used to evert the sleeve 100. This canbe used as an alternative way to determine when the sleeve is fullydeployed. The volume measurement can be used to determine when enoughfluid has been delivered to fully deploy the sleeve 100. The pressuremeasurement can be used to detect the pressure drop once the sleeve isfully deployed and the distal end 112 of the sleeve opens up to allowthe fluid to pass through with less back pressure. Alternatively, if thedistal end of the sleeve is designed not to open up after completeeversion, the pressure will increase upon full deployment of the deviceand indicate that toposcopic delivery is complete. Furthermore, thepressure or delivered volume measurement device can be utilized toprevent complications of over-filling, such as sleeve or tissue aneurysmformation or perforation, as described further below.

In one embodiment, filling catheter 400 passes into the lumen of sleeve100 and a fluid-tight seal 468 is created between the proximal end ofsleeve 100 and the distal end of filling catheter 400, as shown in FIG.5. Various ways to create a permanent or temporary (i.e., releasable ornon-releasable) seal can be used as described herein and/or known in theart. The distal end 112 of sleeve 100 may then be advanced proximallyinto the lumen of filling catheter 400. Tubing 470 can be utilized toprovide a passageway between filling catheter 400 and device 416. Inthis embodiment, a temporary barrier 466 can be created at distal end112 of sleeve 100. Temporary barrier 466 may be created by collapse ofdistal end 112 caused by the influx of fluid through filling catheter400. In other embodiments, distal end 112 can be blocked with anabsorbable or degradable plug comprising cellulose, sugar-basedsubstances, PLA, as well as other techniques discussed elsewhere herein.

Various embodiments of filling catheter 400 are contemplated by thepresent invention. In one embodiment, as shown in FIG. 6A, fillingcatheter 400 is a pushable tube 424 with an optionally releasable clampor other connection 425. If releasable, clamp 425 may be released in anyof a variety of ways, such as by pulling a pull wire which extendsproximally through the overtube. Alternatively, if configured tofunction just as an access and/or delivery device, the clamp 426 orother connection does not need to be releasable, such as a glued,welded, sutured, or created as a one-piece construction with the fillingcatheter. In the illustrated embodiment, sleeve 100 extends proximallythrough the lumen of pushable tube 424 and sleeve rim 432, where theproximal end of sleeve 100 is inverted over and releasably (oralternatively non-releasably) secured to the distal end 422 of tube 424.

FIG. 6B is a longitudinal cross-sectional view of pushable tube 424showing distal end 422 of tube 424 over which sleeve rim 432 isinverted. FIG. 6C is a transverse cross sectional view of an overtube600 showing the available working volume 430 remaining within the lumenof overtube 600 for filling catheter 400 when endoscope 448 is withinthe lumen.

FIG. 7A is a transverse cross section of endoscope 448 and collapsiblefilling catheter such as lay-flat tube 444 within overtube 600 with tube444 lying on top of endoscope 448. Lay-flat tube 444 may be attachedwith means 460 to the outside of endoscope 448 as shown in FIG. 7B toaid in its insertion because the floppiness of tube 444 rendersadvancement on its own difficult. Alternatively, the lay flat tube canbe grasped near the connection with the proximal end of the sleeve 100and advanced with an endoscope and advanced to the desired locationwithout any direct connection between the lay flat tube and the body ofthe endoscope. See, e.g., FIG. 10.

FIG. 7B depicts tube 444 lying on top of endoscope 448 and means 460comprising bands 462 wrapped around endoscope 448 and attached to orformed as a part of the tube 444 to attach tube 444 to endoscope 448.Means 460 for attachment can also comprise attachment strips 452, asshown in FIG. 7C, that wrap around at least a portion of thecircumference of endoscope 448 and are attached on one side of the layflat tube 444. Tube 444 is placed on top of endoscope 448 and strips 452are attached to endoscope 448 by virtue of the adhesive properties ofthe outward facing surface of strips 452 or by a spring force of thestrips 452 that lock onto the housing of the endoscope. Other means 460for attachment can be used to secure tube 444 to endoscope 448 such as adirect adhesive bond between tube 444 and endoscope 448, first andsecond complementary mechanical interfit structures, or others as wouldbe understood by those skilled in the art. The means 460 for attachmentshould allow tube 444 to expand during filling or flushing with fluid.

In other embodiments, filling catheter 400 comprises a semi-rigid (fixedcross sectional configuration) catheter 456 which lies adjacentendoscope 448. Semi-rigid catheter 456 can have a crescent orbanana-shaped cross-sectional configuration as shown in FIG. 8.Banana-shaped semi-rigid catheter 456, like lay-flat tube 444 (when inthe expanded configuration), has a central lumen with a cross sectionalarea sufficient to receive sleeve 100. Also shown in FIG. 8 is thedimension of the inner diameter 457 of overtube 600 within whichendoscope 448 and catheter 456 would reside. In some embodiments,endoscope 448 has an outer diameter of about 12 mm and inner diameter457 is about 16 mm, leaving a working volume with a transverse dimensionof about 4 mm for catheter 456.

In both the lay flat tube 444 configuration and the semi-rigid catheter456 these devices are alternative devices to the filling catheter 400.Thus, the sleeve 100 (not shown) would be inverted with the distal end112 retracted proximally into the tube 444 or 456 and the proximal endfolded over the distal end of the lay flat tube 444 or semi-rigidcatheter 456.

In another embodiment the filling catheter 400 may lack sufficientcolumn strength to be pushable. See FIG. 9. In this embodiment thefilling catheter 400 comprises a flexible collapsible conduit for thepressurized medium to act on the everting sleeve.

A separate device is used to provide sufficient column strength to getthe distal end 402 of the inverted device to the desired delivery point.The separate pushable device could be a pushable rod, catheter, or anyof the types of endoscopes commonly used in GI procedures. These includecolonoscopes, pediatric endoscopes, enteroscopes or the double balloonenteroscopes used for accessing small intestine.

The filling catheter 400 could be attached along the length of thepushable device in a piggy-back fashion with the use of clips, adhesivesthermal bonding or any of the other methods that would be known to thosewith skill in the art. Alternatively, the pushable device could only beattached to the filling catheter 400 at or near the interface of thefilling catheter with the everting sleeve. The pushable delivery devicecould be attached at this point or devices such as graspers or clamps,such as those that can be used through a working channel of an endoscopecould be used to hold the filling catheter and drag it through the lumento the desired delivery point. See FIG. 10. The filling catheter 400could have a “lay flat” design that reduces its cross sectional profilein at least one direction. An example of this lay-flat shape crosssection would be crescent shaped. The crescent shaped cross sectionwould allow for maximum cross sectional area of the filling catheterwhile still having an endoscope along side it in a lumen.

Referring to FIG. 10, there is schematically illustrated an endoscope448 which has been advanced into position adjacent the pylorus. Agrasper or other connecting tool 170 extends through a working channelon the endoscope 448, for grasping or otherwise removably connecting tothe filling catheter 400. This configuration enables the endoscope 448to “pull” a filling catheter 400 by its distal end, in a distaldirection to position the filling catheter 400 at the appropriate sitein the anatomy. Filling catheter 400 for this purpose, may have a highlyflexible construction with relatively low pushability.

Referring to FIGS. 11A and 11B, there is disclosed a steerable fillingcatheter 400 in accordance with the present invention. The steerablecatheter 400 may be guided to the desired site, through a combination ofdistal pushing and bending of the catheter body.

Steerability may be accomplished in any of a variety of ways, such asthrough the use of one or more pull wires. Referring to FIG. 11B, thereis illustrated a cross-sectional view through the filling catheter 400.The catheter 400 comprises an elongate flexible tubular body, having aproximal end and a distal end. The tubular body may comprise amulti-lumen extrusion, as is understood in the catheter arts. Thecatheter 400 includes a tubular wall 178 defining at least one centrallumen 180 extending axially therethrough. Within or adjacent the wall178 there is provided at least one axially extending lumen 172 foraxially moveably receiving a pull wire 173. Pull wire 173 is configuredsuch that proximal retraction of the pull wire 173 with respect to thewall 178 causes a deflection of the distal end of the filling catheter400.

Preferably, at least a second lumen 174 for axially moveably receiving asecond pull wire 175 is also provided. The pull wires 173 and 175 may beoriented at approximately 180° apart from each other, with respect tothe longitudinal axis of the catheter 400. A third and a fourth pullwire may also be provided, depending upon the desired functionality ofthe catheter 400.

The implementations of the invention discussed above have been primarilydirected towards providing access to a remote location in the body. Thetoposcopic sleeves of the present invention may additionally be utilizedto deliver articles to remote sites, as discussed below. The delivereddevice may be a diagnostic or therapeutic device, or an alternativeaccess system such as a guidewire or rail. The delivered device may bedetached at the delivery site and left in place (an implant) or removedfrom the body following the diagnostic or therapeutic procedure.

Referring to FIG. 12A, there is illustrated a delivery device inaccordance with the present invention. The delivery device includes afilling catheter 400, illustrated as extending across the stomach suchthat a distal end 402 is in the vicinity of the pylorus 116. Atoposcopic sleeve 100 is proximally retracted within the fillingcatheter 400 as has been discussed.

The distal end 112 of the toposcopic sleeve 100 is closed, and providedwith a connector 200. As illustrated in FIG. 12B and as will be apparentin view of the preceding discussion, the connector will advance distallyin response to the introduction of inflation media through fillingcatheter 400.

The connector 200 may be removably or permanently connected to any of awide variety of devices, examples of which have been identified above.In FIG. 12A, the connector 200 is connected to a guidewire 152. As thesleeve 100 is everted distally, the connector 200 advances distally,pulling guidewire 152 in a distal direction. In this manner, a guidewire152 may be distally axially advanced through a tortuous pathway, withinthe sleeve 100.

Following complete evertion of the sleeve 100, the connector 200 may becaused to release the guidewire 152. Release may be accomplished in anyof a variety of ways, such as by introduction of a solvent throughsleeve 100, introduction of a solvent around the outside of the fillingcatheter 400, thermally releasing a polymeric link through the use of amonopolar or bipolar electrical circuit as is understood in thedetachable intracranial aneurysm coil field, or the like. Alternatively,the guidewire 152 may comprise a hollow outer sleeve which axiallyslideably receives an inner core. Axial, proximal or distal displacementof the core with respect to the sleeve can be utilized to detach theconnector 200. The guidewire may also be forceably detached, by apushing, twisting or pulling motion.

Following detachment of connector 200 and opening of the distal end ofthe sleeve, the sleeve 100 may be proximally retracted leaving theguidewire 152 in place. Alternatively, devices may be advanced along theguidewire 152 through the sleeve 100, leaving the sleeve 100 inposition.

Any of a wide variety of alternative devices may be attached to thesleeve 100 at connector 200. These include various sensors, or otherdiagnostic or therapeutic devices described above.

An alternative guidewire placement system is illustrated in FIGS.13A-13D. Referring to FIG. 13A, an elongate flexible tubular fillingcatheter 400 is provided in a dual lumen configuration. A first lumen210 is provided for receiving the toposcopic sleeve 100 as has beendiscussed. Toposcopic sleeve 100 may be provided with a connector 200,for connection to a pull wire 152.

The filling catheter 400 is additionally provided with a second wireguide or lumen 212. Two lumen tubular bodies may be formed in accordancewith extrusion techniques which are well understood in the medicalcatheter arts.

The second lumen 212 receives a guidewire 214. The guidewire 214 is theprocedure guidewire which is to be left in position following removal ofthe filling catheter 400.

Referring to FIG. 13A, the procedure guidewire 214 extends around thedistal end 402 of the filling catheter 400 and into the interior of thetoposcopic sleeve 100. In the illustrated embodiment, the distal end 216of guidewire 214 is positioned in the vicinity of the connector 200.

As the connector 200 is advanced distally in response to introduction ofinflation media, the sleeve 100 everts in a distal direction, and theguidewire 214 is laid down along the outside of the sleeve 100.

Referring to FIG. 13C, following complete deployment of the toposcopicsleeve 100, the guidewire 214 has been laid down along the pathway untildistal end 216 is released from the toposcopic sleeve 100.

Referring to FIG. 13D, proximal retraction on pull wire 152 proximallyretracts the toposcopic sleeve 100 back into the filling catheter 400,leaving the guidewire 214 in position along the desired access pathway.The filling catheter 400 may thereafter be proximally retracted, as maybe desired, leaving the guidewire 214 extending throughout the length ofthe desired access pathway.

Proximal retraction of the filling catheter 400 is preferablyaccomplished in a manner that does not displace guidewire 214. This maybe accomplished by providing a guidewire 214 having a sufficientproximally extending length that the portion extending outside of thepatient is longer than the length of the filling catheter 400.Alternatively, the filling catheter 400 may be constructed in a rapidexchange configuration, in which the guidewire 214 exits a proximal sideaperture on filling catheter 14 which is in communication with thesecond lumen 212. The side aperture may be positioned along the lengthof the filling catheter 400, such as within about 10 or 20 cm of thedistal end.

The leading bend 154 on toposcopic sleeve 100 may be characterized by a180° turn having a relatively small radius of curvature. This mayprevent the use of a relatively stiff guidewire, as will be appreciatedby those of skill in the art.

For this purpose, the guidewire 214 may comprise a highly flexible,small diameter outer sleeve having a removable central stiffening coretherein. The outer guidewire sleeve may be toposcopically deployed asillustrated in FIGS. 13A-13D. Following complete deployment of theguidewire sleeve, the central stiffening core may be distally advancedtherethrough, to form a final guidewire construct. Alternatively, theflexible guidewire sleeve may be proximally retracted followingplacement of the guidewire core, leaving the guidewire core in place tofacilitate a subsequent access. The guidewire sleeve may comprise any ofa variety of configurations, such as a thin walled collapsible polymerictube, or a spiral wrapped tube comprising a polymeric or flat metalribbon as are understood in the flexible catheter arts.

Referring to FIG. 13C, the guidewire 214 extends along the outside ofthe fully deployed toposcopic sleeve 100. As an alternative, a lumen maybe provided within the wall or attached to the wall of the toposcopicsleeve 100 to enclose the free end of the guidewire 214. This lumen maybe formed by bonding a concentric sleeve to the toposcopic sleeve 100 toprovide a dual layer sleeve, having a mandrel removably positionedduring the bonding process such removal of the mandrel results in aguidewire lumen which may be in communication with the second lumen 212.Alternatively, a flexible sleeve may be bonded to the exterior surfaceof the toposcopic sleeve 100. Removal of the filling catheter 400 may beaccomplished as previously described, leaving the guidewire 214 inposition to provide subsequent access to the target site.

The toposcopic tube may be made from any of a variety of materials,depending upon the desired performance of the finished device.Polyurethane may be a preferred tube material for certainimplementations, as it has low distensibility (that is, stress risesrapidly and non-linearly with strain), and is tough andpenetration-resistant. For colonoscopy, a polyurethane liner may have adiameter between about ½ inch and 1 inch, and a wall thickness betweenabout 0.002 inch and 0.007 inch. Polyurethane tube about ¾ inch indiameter and having a wall thickness 0.003 inch formed by dielectricsealing of 3 mil polyurethane sheet can be everted using fluid pressuresof a few pounds per square inch, when lubricated as described furtherbelow.

Latex rubber may also be a suitable tube material for low pressureeversion. A latex liner may have an inner diameter between about ½ inchand about 1 inch, and a wall thickness between about 0.010 inch and0.030 inch. Latex tube about ¾ inch in diameter and having a wallthickness 0.015 inch can be everted using fluid pressures in the range1-2 pounds per square inch when well-lubricated. Latex may be lesspreferred than polyurethane, however, as latex is more easily stretchedand distended than polyurethane.

In general, the sleeve should be made of a material that allows it to besufficiently flexible to conform to the shape of a device being placedtherethrough. For most applications, the material, which is typicallythin, should exhibit resistance to tearing and stretching (i.e., havegood linear strength). Generally, the sleeve should be smooth andlubricious such that the sleeve, as it is laid down by the advancementof the device, or being withdrawn from the body, is atraumatic todelicate linings of the body, such as sphincters, tissue folds, ducts,and other passages. Another material with desirable properties isexpanded polytetrafluoroethylene (ePTFE). Custom extruded ePTFE, whichis available from Zeus Medical Products, Inc., Orangeburg, S.C., isproduced from polytetrafluoroethylene (PTFE) tubing that is expandedunder controlled conditions which advantageously adds microscopic poresthroughout the material. The result is a soft, flexible material withincreased linear strength. The wall thickness of the sleeve dependslargely on the application and material used and may typically rangefrom 0.001-0.01″ for ePTFE. A more preferred range for ePTFE whenintroducing a standard ERCP device would be in the 0.002-0.005″ range,most preferably around 0.0025″. Many other polymeric films, such ashigh-density or low-density polyethylene, have desirable properties,particularly those with adequate linear strength. Their lower cost canbe significant, particularly for longer devices. Other possiblematerials include latex, woven fabrics, or biomaterials that can befabricated into a thin, flexible sheet or tube of sufficient strength.The sleeve can also be coated or impregnated with other compounds andmaterials to achieve the desired properties.

In some embodiments, the sleeve itself may be degradable and formulatedto dissolve within a desired time such as no more than approximately 1day, 3 days, 7 days, 14 days, 1 month, 3 months, 6 months, 9 months, 12months, 18 months, 24 months, or 36 months. This can be advantageouswhen the sleeve is used primarily as a delivery device for anotherdiagnostic or therapeutic device as described elsewhere in theapplication, or if the sleeve is intended as a temporary bypass, suchthat a subsequent removal procedure for the sleeve becomes unnecessary.

In some embodiments, the sleeve may be made of a biodegradable polymer.Examples of polymers that may be used for the biodegradable sleeveinclude, for example, poly(L-lactide) (PLLA), poly(D,L-lactide) (PLA),polyglycolide (PGA), poly(Llactide-co-D,L-lactide) (PLLA/PLA),poly(L-lactide-co-glycolide) (PLLA/PGA), poly(D, L-lactide-co-glycolide)(PLA/PGA), poly(glycolide-co-trimethylene carbonate) (PGA/PTMC),polyethylene oxide (PEO), polydioxanone (PDS), polycaprolactone (PCL),polyhydroxylbutyrate (PHBT), poly(phosphazene),polyD,L-lactide-co-caprolactone) (PLA/PCL),poly(glycolide-co-caprolactone) (PGA/PCL), polyanhydrides (PAN),poly(ortho esters), poly(phoshate ester), poly(amino acid), poly(hydroxybutyrate), polyacrylate, polyacrylamide, poly(hydroxyethylmethacrylate), elastin polypeptide co-polymer, polyurethane,polysiloxane and their copolymers.

A film (a sheet or layer) of polyurethane (an elastomeric material) maybe laminated with lubricous coatings (layers) of polyvinylpyrrolidone(PVP) by applying heat and pressure between the film and coatings withheated rollers. PVP is a linear polymer which forms a lubricous coatingon the polyurethane when wet. The resultant laminated polyurethane-PVPsheet may then be formed into multiple tubes each of which will serve asan everting tube and has interior and exterior surfaces of PVP. Thetubes are preferably sufficiently thin, pliable, and slippery to be usedin endoscopy, and yet rugged enough to withstand the puncture forcesthat are apt to be applied during use.

The PVP surfaces of the laminated tubes are quite lubricous,particularly when exposed to water during emplacement of the liner,thereby facilitating both the emplacement of the tube into the colon orother lumen and the insertion and manipulation of the colonoscope withinthe tube. The PVP coatings are durable and do not deteriorate or peeloff in storage or during use, and because the PVP is laminated to thepolyurethane, the everting tubes include no adhesive to possiblyharmfully interact with body tissue during use. Although some of the PVPwill dissolve in water during use, the lamination procedure embedssufficient PVP in the polyurethane surfaces to maintain lubricousnessthroughout the colonoscopic procedure. The durability of the coating(i.e., its resistance to removal by dissolution in the presence ofwater) can be increased by forming cross-links in the PVP through theapplication of heat or gamma radiation, as is understood in the art.

The fluid pressure for effecting eversion causes the stored portion ofthe tubing to collapse upon itself. Without lubrication, the collapsedtubing walls tend to stick to one another with a force that increaseswith increasing pressure, so that it may be desirable to use tubematerials having a low coefficient of friction, or to provide alubricant that is sufficiently viscous that it is not substantiallydisplaced from the contacting wall surfaces under the pressure of thefluid.

Moreover, the everting fluid itself will preferably have some degree oflubricity to aid in minimizing the friction between the collapsed, notyet everted, inner portion of the tube and the everted outer portion ofthe tube as the inner portion slides against the outer portion duringeversion. The viscosity of the everting fluid is preferably low enoughto minimize the pressure drop between the chamber and the evertingmargin.

For latex tube materials, suitable lubricants for the everting fluidinclude an aqueous hydrogel such as, for example, K-Y Jelly mixed withwater in a proportion as great as about 30% jelly, and preferablybetween about 1:10 and 1:5. A suitable lubricant for the contactingsurface of the collapsed tubing is an aqueous hydrogel such as, forexample, K-Y Jelly and water in a proportion at least about 1:2.

An aqueous hydrogel can be suitable for a lubricating everting fluid fora polyurethane tube as well, as described generally in, for example, D.R. Shook et al., 1986, Trans. ASME, Vol. 108, pp. 168-74. Morepreferably the coefficient of friction of polyurethane tube and/or ofthe guide/storage tube is reduced by coating the wall surfaces with ahydromer such as, for example, polyvinylpyrrolidone (“PVP”), which has avery low coefficient of friction when wet, as described generally in,for example, D. R. Shook et al., 1986, Trans. ASME, Vol. 108, pp.168-74.

Other tube materials can be used, such as natural and synthetic rubber,silicone rubber, polyethylenes, segmented polyurethanes, polyolefinssuch as polyethylene and polypropylene, copolymers of ethylene orpropylene and vinyl acetate, polyvinyl chloride or copolymers of vinylchloride, woven materials, Kevlar, Mylar and the like. The tubing can bereinforced using, for example, materials such as synthetic fibers orthreads derived from cotton, silk, nylon, polyester, and the like.

Other lubricants can be used, such as water alone, water containinghydroxyethylcellulose (for example, Natrosol®) or other water“thickeners” such as other cellulose derivatives and glycerin, watercontaining a surfactant or a mixture of surfactants, or mineral orvegetable oil.

The dimensions of the tube can be selected to adapt the apparatus forany of a wide variety of applications ranging from human adult to humanpediatric use, as well as for veterinary uses in any of various mammals.It will be appreciated that the tube can be used to facilitate insertionof any of a wide variety of diagnostic or therapeutic instruments and tofacilitate insertion of instruments such as, for example, endoscopes,into any natural or created body passages. A tube having a diameterabout ¾ inch and a length at least 80 inches can form an everted tubehaving a length at least 30 inches when fully everted within theintestine suitable for colonoscopy in an adult human. A shorter tubehaving a diameter about ¾ inch can form a tube having an everteddiameter as described for colonoscopy and an everted length about 12inches, suitable, for example, to facilitate insertion of asigmoidoscope.

The length and shape of the sleeve can be quite variable, depending onthe application. As shown schematically in FIG. 13E, in an embodimentused as a biliary catheter for an ERCP procedure in an adult patient,the delivery catheter 400 preferably has a side-port for delivery of asleeve 100 that is preferably tubular and typically measures from 6-10cm in length, preferably 7-8 cm, so that an inner member (not shown),such as an ERCP scope or a stent, can cannulate both the opening of thecommon bile duct 1004 at the sphincter of Oddi 1002 and any stricturesthat may exist therein. Preferably, the sleeve 100 should not be so longthat it cannot completely evert during the procedure, since in thisparticular embodiment, removal of the sleeve 100 is desired after theinner member is in position. An everting sleeve configured to cannulatethe biliary tree via the sphincter of Oddi can be especiallyadvantageous, as multiple unsuccessful attempts to cannulate the bileduct via conventional ERCP can increase the risk of complications suchas subsequent biliary duct or sphincter stenosis as well as post-ERCPpancreatitis.

Other procedures may require a longer sleeve. For example, the sleeveused to introduce a standard feeding tube, e.g., a nasal-gastric (NG) ornasal jejunal feeding tube, would be more in the 20-40 cm range, morepreferably around 30 cm. The sleeve is used to protect the feeding tubethrough the nasal passage past the deviation of the septum until itreaches the back of the throat where natural peristalsis takes over andhelps to urge the feeding tube downward through the esophagus and intothe stomach or jejunum.

A shorter sleeve, e.g., 7-10 cm may be desired for nasal introduction ifthe inner member is merely serving as a short conduit for the subsequentintroduction of another device, such as an endoscope, therethrough. Thesecond device can then be introduced much more comfortably than would beotherwise possible. Conversely, a much longer sleeve, e.g., 150-160 cm,might be used for a colonic procedure. Ideally, the sleeve for aparticular application, should be properly sized such that it completelyeverts from the inner member, if so desired, to allow it to be removedwhile maintaining the inner member within the patient.

In some embodiments, the toposcopic deployment system includes one ormore safety devices designed to reduce the risk of damage, e.g.,aneurysm formation or perforation, to the sleeve, body lumen and otherassociated structures of barotrauma or volutrauma. When delivering asleeve toposcopically, at least three delivery pressures should be takeninto account: (1) the internal sleeve pressure (e.g., when the distalend of the sleeve is tightly sealed); (2) the pressure thedistally-advancing sleeve exerts on the wall of the body lumen (e.g., anintestine); and (3) the pressure that might be exerted on the bowel fromthe inflation media used to evert the sleeve. As described above herein,the distal end of the sleeve is preferably sealed such that all orsubstantially all of the internal sleeve pressure created by infusion ofinflation media within the sleeve is not transmitted to the body lumenoutside of the sleeve. By successfully sealing the sleeve, preferably nopressure should be exerted on the bowel from the inflation media used toevert the sleeve. The internal sleeve pressure is preferably below thepressure required to deform the sleeve, as deformation of the sleeve(e.g., aneurysm formation) can undesirably allow transmission ofpressure to the body luminal wall, such as via direct contact betweenthe sleeve aneurysm and the body luminal wall, which can in turn causedamage to the body luminal wall. While the deformation pressure of thesleeve depends on a variety of factors, including the material anddimensions of the sleeve, in some embodiments, it is desirable tomaintain the internal sleeve pressure at no more than about 10, 9, 8, 7,6, 5, 4.5, 4, 3.5, 3, 2.5, 2, 1.5, 1 psi, or less. The use of amechanical assisting device, such as a push wire or snare, as describedfurther below, can enable the use of a lower eversion pressure thanwould have otherwise been required to provide a given net distal forceon the inside of the toposcopic sleeve. One point in which this can beespecially advantageous is when the inverted sleeve needs to overcomethe frictional force of the filling catheter against the sleeve topromote eversion of the sleeve.

The distally-advancing sleeve can also exert a pressure on the bodylumen when, for example, the sleeve contacts a wall of the body lumen.One specific example is when the sleeve navigates around a sharp turn orbend in the lumen, such as an intestinal wall. Deploying the sleeve at ahigh velocity, which may occur when the sleeve is filled with inflationmedia at a high pressure, can increase the pressure transmitted from thesleeve to the luminal wall, causing complications such as bleeding, if avessel is contacted, or perforation. Furthermore, a deformed portion ofthe sleeve (e.g., a sleeve aneurysm) could also come into direct contactwith the body lumen wall, causing damage. Perforation of a body lumensuch as the intestine may cause life-threatening peritonitis caused bytranslocation of gut flora into the sterile peritoneal cavity, oftennecessitating emergent surgical repair. Therefore, it is desirable tokeep the pressure exerted by the sleeve on the wall of the body lumen toa pressure less than the pressure required to deform the body luminalwall (e.g., the aneurysm pressure), which may be, in some cases, no morethan about 4, 3.5, 3, 2.5, 2, 1.5, 1 psi, or less. Safety devices thatwill mechanically assist in reducing the net pressure the sleeve exertson the body lumen, such as control wires and grasping devices such asloop snares are disclosed herein. In some embodiments, the safetydevice, such as a control wire can function as a “brake” to reduce thevelocity of the distally advancing sleeve by providing a proximallyretracting force on the sleeve, which in turn will reduce the netpressure the sleeve exerts on the luminal wall when the sleeve comesinto contact with the luminal wall. The safety device, e.g., a controlwire can also mechanically assist in eversion of the sleeve, reducingthe internal sleeve pressure and thus reducing the risk of sleevedeformation that could in turn transmit pressure to the body luminalwall by direct contact, or alternatively by the inflation media if thesleeve actually ruptures.

In some embodiments, it may be desirable to provide mechanicalassistance to supplement the deployment force provided by the inflationmedia, to evert the sleeve, or alternatively to provide a proximallyretracting force on the sleeve in some embodiments. Such a control wiremay have pushing and/or pulling capabilities with respect to the sleeve.In some embodiments, mechanical assistance can be conveniently providedby axially distally advancing a push wire or other pushable structure,inside of the sleeve as the sleeve everts. The push wire may compriseany of a variety of structures having sufficient flexibility to navigatethe GI pathway, and sufficient pushability to exert a distally directedforce on a distally advancing aspect of the sleeve. The net distal forceon the distally advancing end of the sleeve will be the sum of the forceattributable to the inflation media, and the force attributable to thepush wire if one is used. The use of a push wire thus enables the use ofa lower eversion media pressure than would have otherwise been requiredto provide a given net distal force on the inside of the toposcopicsleeve. This can be especially advantageous, for example, at the startof the eversion process when the sleeve is inverted within the fillingcatheter, and the sleeve needs to overcome the frictional force of thefilling catheter against the sleeve to promote eversion of the sleeve.

The control wire, which may be a push wire, may be configured in eitherof two basic forms. In one, a distal end of the push wire is advancedagainst the inside surface of distal end 154, as it advances distally.In this configuration, the distal end of the push wire is in slidingcontact with the inside surface of the sleeve, and is preferablyprovided with a blunt tip as well as a low friction surface or coating.In an alternate configuration, the push wire is attached to the distalend 112 of the sleeve, and is advanced distally along with the eversionof the sleeve. Preferably, the push wire is releasably attached to thesleeve, so that it may be released and removed following fulldeployment. This may be accomplished, for example, by the provision of areleasable connector such as an erodable bond, releasable snap or otherinterference fit structure, or a push wire having a distal graspingmember such as a snare for grasping the distal end 112. In someembodiments, the push wire is releasably attached to the sleeve but doesnot reside within the lumen of the sleeve along its length. The pushwire can be housed, for example, within a separate lumen in the fillingcatheter in these embodiments.

In one implementation, the control wire includes a grasping member canbe a semi-rigid elongate member, such as a snare, and configured toprovide a mechanical force on an inverted distal end of the sleeve topromote eversion, (or to promote elongation if an axially compressedaccordion-like sleeve is utilized). The grasping member can also beutilized to invert the sleeve prior to eversion. The grasping member canbe used in combination with, or a substitute for inflation media used ineverting a sleeve, as described elsewhere in the application.

Use of a grasping member in combination with inflation media foreversion of a sleeve can advantageously allow for use of a lowerinflation media pressure and/or volume as some of the force can beprovided mechanically by the eversion-assisting member. Furthermore,using the grasping member to function as a “brake” to reduce thevelocity of the distally advancing sleeve by providing a proximallyretracting force on the sleeve, can advantageously reduce the netpressure the sleeve exerts on the luminal wall when the sleeve comesinto contact with the luminal wall, as described above. As noted,maintaining the internal sleeve pressure at a pressure below thedeformation pressure of the sleeve, as well as keeping the pressure thesleeve exerts on the wall of the body lumen at a pressure below thedeformation pressure of the wall of the body lumen can reduce the riskof barotrauma or volutrauma to the sleeve, body lumen, or otherstructure which in turn can undesirably lead to complications such asaneurysm formation or perforation.

In some embodiments, the grasping member is a loop snare. Other graspingmembers as known in the art such as forceps, jaws, clamps, and the likecan also be used. The snare can be made of any appropriate materialknown in the art. In some embodiments, the snare may be made of a metalsuch as stainless steel. In other embodiments, the snare may be made ofnitinol or a shape-memory polymer.

FIGS. 14A and 14B show top and side views, respectively, of oneembodiment of a loop snare that can be utilized to facilitate toposcopicdelivery of a sleeve. The snare includes a proximal member 10 and adistal segment 20. The distal segment 20 includes a loop formed of anappropriate material, such as a metal, for example, a superelastic alloywire. Although the loop may be of any useful shape, it is desirablygenerally either circular or elliptical in shape. While an axis of theloop may be parallel to the long axis of the proximal member 10, it ispreferred that an axis of the loop is not parallel to the axis of theadjacent portion of proximal member 10 and, in some embodiments, it issubstantially perpendicular thereto. When the loop is deformed andinserted into the proximal end of a catheter, this axis will generallycoincide with the axis of the proximal member.

Adjacent the ends of the loop, the two sides of the loop can graduallytaper away from the axis. This makes initial insertion of the deviceinto a catheter easier than if the two sides of the loop diverged fromone another more sharply. As the device is entered into the lumen of thecatheter, once a small portion of the loop has entered the lumen, thecatheter walls will easily collapse the rest of the loop about the axisso that the two sides of the loop are held close to one another withinthe catheter lumen.

In a preferred embodiment, the distal segment 20 includes a distal tip25 which facilitates entry of the loop into the proximal end of acatheter. Desirably, the tip includes a generally U-shaped arch 26 atits distal end with each leg 27 extending rearwardly toward the loopfrom a side of the arch. These legs may be substantially parallel, asshown, or they may taper slightly away from one another. Although thelegs could also taper toward one another away from the arch without anysignificant loss in utility, this embodiment is generally not preferredbecause then the transition from the tip to the loop is more abrupt.Desirably, this transition is fairly gradual, with the legs of the tipmeeting the respective sides of the loop at an obtuse angle. This makesinsertion of the snare into the catheter easier because there is nosharp bend in the wire to impede entry.

The loop and the distal tip desirably lie generally flat in a singleplane, as shown, but the major axis of the loop may instead be curved.If such a curved configuration is utilized, it is preferred the apex ofthe curve be disposed away from the proximal end of the device.

In the substantially planar embodiment illustrated in FIGS. 14A and 14B,the axis of the proximal member 10 meets the plane containing the loopat an angle alpha which in some embodiments is between about 45-135degrees. An angle of about 90 degrees may present the full area of theloop in a distal direction, enhancing the ability to slip the loop overtail members 801 on the distal end 112 of the sleeve 100 (not shown).This angle alpha is provided between the loop and the proximal segmentby forming bends 29 in the wire 21 of the loop at a position adjacentthe distal end of the proximal member 10. These bends 29 are desirablygenerally rounded, yet provide the desired angle in a relatively shortdistance.

FIG. 14C schematically illustrates the loop snare 700 in a perspectiveview, as well as better illustrating various features of the snare 700.In contrast to the embodiments depicted in FIGS. 14A-14B, the loop snare700 depicted in FIG. 14C shows the proximal member 10 substantiallycoaxial with the distal member 20, which could advantageously minimizethe profile of the snare while in use. The proximal member 10 cancomprise a single, elongate member which extends proximally from thesebends 29 and is secured thereto. In a preferred embodiment, the proximalmember 10 comprises two parallel wire segments 11 that are grippedtogether, or bonded to, one another. Desirably, these two wire segments11 are extensions of the single wire 21 defining the loop. The two wires11 may be bonded or gripped together by any convenient means to avoidrelative axial movement therebetween. Inasmuch as shape memory alloysare often relatively difficult to braze or solder, an organic adhesive,such as an epoxy resin, is preferred. The proximal member 10 may alsoinclude an outer sheath 13 carried about these two wire segments 11 toreduce friction between the proximal member 10 and the lumen of thecatheter as the snare is passed therethrough. The sheath 13, which mayserve to grip together the wire segments 11, may cover substantially theentire length of the proximal member 10, or it may terminate at aposition spaced away from the proximal end of this member 10, asdesired. Preferably, the wall of the sheath 13 is very thin, e.g., onthe order of about 0.002-0.010 inches in thickness, to keep the outerdiameter of the entire proximal member 10 small; this allows use of theloop snare with catheters of smaller inner diameter. Shrink wrap tubingof polytetrafluoroethylene or the like may be employed to form thesheath 13. After the wires 11 are passed through the shrink wrap tubing,the tubing may be heated to cause it to shrink into tight engagementwith the wire segments 11. Catheter 40 circumscribes proximal member 10and is configured such that relative movement between the catheter 40and the proximal member 10 and distal portion 20 of the snare 700 allowsfor releasable grasping of, for example, distal tails of a sleeve topromote inversion or eversion of the sleeve.

In some embodiments, the distal portion 710 of the catheter 40 (tubingsurrounding the snare wire(s)) is tapered as shown schematically in FIG.14C to increase flexibility of the snare 700, such that it can moreeasily navigate turns and bends within a body lumen. In someembodiments, no more than about 5 cm, 10 cm, 15 cm, 20 cm, or 25 cm ofthe distal tubing portion 710 is tapered such that the radial thicknessof the distal tubing 710 gradually decreases distally.

In some embodiments, the snare may be as described or modified from U.S.Pat. No. 5,171,233 to Amplatz et al. or U.S. Pat. No. 6,913,612 toPalmer et al., which are both incorporated by reference herein in theirentirety.

A grasping member such as a loop snare can be used to form a seal withrespect to the distal end of a sleeve as follows. In FIG. 14D, a sleeve100 as shown in FIG. 1C with a plurality of distal tail members 801 isillustrated with the distal portion 20 of loop snare 700 extendingdistally out from the lumen of the sleeve 100. The distal portion 20 ofsnare 700 is then actuated to sequentially fold down each tail member801, such as at its distal end 803 such that the tail members 801overlap, such as piled on top of one another as shown, preferably in anaxis that is substantially orthogonal to the long axis of the sleeve100, as shown in FIG. 14E. The loop 20 of the snare 700 can then becinched such that the tail members 801 and the loop of the snare 20 forma fluid-tight or near fluid-tight seal at the distal end 112 of thesleeve 100, as shown in FIG. 14F. the sleeve can be pinned between theloop 20 and the distal tip of the snare loop catheter 40. The cinchingbe performed by either (1) retracting one strand of the folded wire,making the loop smaller, or (2) relative movement between the wire andthe catheter, such as by advancing the catheter over the wire until itclosely contacts the ensnared distal tail members 801. The snare 700 canthen be retracted proximally to invert the sleeve 100 within a deliverycatheter for later eversion, as will be shown in FIGS. 15A-G below. Inother embodiments, rather than the loop 20 of snare 700 sequentiallyfolding down each tail member 801 individually to form a seal over thedistal end 112 of the sleeve 100 as shown in FIG. 14E, the tail members801 may all be secured simultaneously using the loop 20 of the snare700, as shown in FIGS. 14G-14H.

A method of using a loop snare within a delivery system to facilitatetoposcopic delivery of a sleeve will now be described, and illustratedin connection with schematic FIGS. 15A-16B. FIG. 15A is a schematicperspective view of a toposcopic delivery system. Shown is the distalportion 20 of the snare 700 about to be threaded through a lumen in aport 900 of a connector, such as the T-connector 906. Other connectors,such as Y-connectors can also be utilized. Snare 700 also has a proximalcontrol element 720 such as a handle to facilitate movement of snare 700as well as to facilitate relative movement of snare catheter 40 (notshown) relative to distal loop 20 to engage distal tail members 801 ofthe sleeve 100. The inflation media control element 416 is shownoperably connected to the lumen of T-connector 906 via port 902. A valve904, which is preferably a one way valve 904 prevents backflow ofinflation media through port 900. Proximal end of sleeve 100 is operablyconnected to the distal end of the filling catheter 400 as describedelsewhere herein.

FIG. 15B is a cut-away schematic view of the toposcopic delivery systemshown in FIG. 15A, and illustrating distal portion 20 of the snare 700through port 900 and about to be threaded through one-way valve 904. Asshown in FIG. 15C, snare 700 is threaded further distally into thefilling catheter 400. Next, as shown in FIG. 15D, the snare 700 isthreaded through the sleeve 100, and the snare loop 20 emerges distal tothe tail members 801 of the sleeve 100. Next, the tail members 801 ofthe sleeve 100 are engaged with the snare loop 20 and a seal is formedas illustrated and described, for example, in connection with FIGS.14D-14F. The snare 700 can then be retracted proximally while operablyengaging the distal tail members 801 (no longer shown for clarity) inorder to invert the sleeve 100, as shown in FIG. 15E. FIGS. 15F-Gillustrates the snare 700 further retracted proximally such that thesleeve 100 is inverted within the filling catheter 400. The fillingcatheter 400 can then be delivered to a patient in preparation foreversion of the sleeve 100, as previously described.

FIG. 15H is a schematic illustration of a sleeve and filling catheterkit 980, with the sleeve 100 inverted within the filling catheter 400,and the proximal end of the sleeve operably connected with the distalend of the filling catheter at 960. Control wire, such as the loop snare700 previously described with a proximal catheter portion 40, can beoperably attached at its distal end 20 to the distal end 112 of thesleeve 100. The snare 700 may also have a releasable proximal element,such as a clamp 770 to maintain the snare wire 10 in place relative tothe filling catheter 400. Hydration tubing 970 preferably is inproximity to or abuts the sleeve as shown. Hydration tubing 970preferably has pores or weep holes 972 to facilitate hydration of thesleeve 100 to assist in the eversion process.

The assembly 980 is preferably contained within packaging 950 in asterile manner. The sleeve inversion process can occur, for example, asdescribed in connection with FIGS. 15A-G above, and can be especiallyconvenient and time-saving as the sleeve inversion process need not beperformed in the operating room immediately prior to toposcopic deliveryin a patient.

In one embodiment, the kit 980 can be used in the following manner.After removal of packaging 950, fluid, such as water or saline, can bedelivered through hydration tubing 970 to hydrate the sleeve 100 inpreparation for eversion. Next, the control wire 700 including clamp 770can be back-loaded through inflation media device connector 906 in aretrograde direction, and out port 900 (elements shown, e.g., in FIG.15A, except delivery catheter 400 is not yet attached to connector 906).In embodiments where the control wire 700 is a grasping member, theclamp 770 can then be removed and replaced by a control handle tofacilitate relative movement of grasping catheter 40 with respect todistal grasping portion 20. The filling catheter 400 can then beattached to connector 906 of inflation media control system and deployedto a body lumen of the patient as described, for example, below. Thecontrol wire 700 may then be removed, or retained for use as, forexample, a guidewire.

Referring to FIG. 16A, there is illustrated a delivery system inaccordance with the present invention. The delivery system includes afilling catheter 400, illustrated as extending across the stomach suchthat a distal end 402 is in the vicinity of the pylorus 116. Atoposcopic sleeve 100 is proximally retracted within the fillingcatheter 400 as has been discussed.

The distal end 112 of the toposcopic sleeve 100, such as at the distaltail members 801 (not shown for clarity) of the sleeve 100 is closedusing a grasping element, such as a loop snare 700 previously described.As illustrated in FIG. 16B and as will be apparent in view of thepreceding discussion, the loop snare 700 can be manually advanced by aphysician to facilitate eversion of the sleeve, concurrently with theintroduction of inflation media through filling catheter 400. Use of aloop snare 700 can advantageously reduce the pressure and/or volume ofinflation media required as previously described. Using a snare-typedevice in combination with inflation media as described above canadvantageously allow for a lower inflation media pressure, which is theinternal sleeve pressure assuming a fluid-tight seal of the distal endof the sleeve.

The loop snare 700 may be removably or permanently connected to any of awide variety of devices, examples of which have been identified above.As the sleeve 100 is everted distally, the loop snare 700 is alsomanually advanced distally, pulling the desired diagnostic ortherapeutic device (not shown) in a distal direction. In this manner, adevice may be distally axially advanced through a tortuous pathway,within the sleeve 100.

After eversion (or axial expansion of the accordion-like sleeveembodiment) has been completed, the snare 700 can be detached from thedistal end 112 of the sleeve 100 and then withdrawn. Alternatively, thesnare 700 can be left in place to serve as a guidewire. In someembodiments, the snare 700 is configured to fit within an endoscopicworking channel The snare 700 preferably has an axial length that isgreater than the length of the sleeve 100 and filling catheter 400.

Use of a grasping member such as a loop snare in connection with thesleeve can be especially advantageous when additional diagnostic ortherapeutic items are delivered along with the sleeve. For example, themethod described above can be used in connection with capsule endoscopy.In capsule endoscopies, a patient swallows a capsule, and a micro-cameratakes thousands of pictures as it travels through the gastrointestinaltract. The camera transmits these images to a special recording deviceusing wireless technology. These images can be transformed into a video,so the physician can see images of the full gastrointestinal tract.However, the specific location within the GI tract in which a particularimage is taken cannot be readily determined. Using the disclosed method,a capsule endoscope can be operably attached to either the distal end ofthe snare or the sleeve. As the total length of the snare as well as thelength of the snare positioned within the patient are known, the preciselocation of the capsule at the time that an image is taken can beadvantageously determined. In a similar fashion, other diagnostic ortherapeutic modalities such as drug delivery, biopsy, cautery,hemostasis, sclerotherapy, embolization, and the like can be performedat a particular location with greater specificity.

While this invention has been particularly shown and described withreferences to embodiments thereof, it will be understood by thoseskilled in the art that various changes in form and details may be madetherein without departing from the scope of the invention. For all ofthe embodiments described above, the steps of the methods need not beperformed sequentially.

We claim:
 1. A method of toposcopically delivering a sleeve to a bodylumen, comprising: providing the sleeve at least partially invertedwithin a filling catheter, the sleeve comprising a proximal end, adistal end, and an elongate body, the proximal end of the sleeveattached to a distal end of the filling catheter; advancing the sleeveand the filling catheter to position the distal end of the fillingcatheter at a first point in the body lumen; and flowing inflation mediawithin the sleeve to promote eversion of the sleeve to a second point inthe body lumen.
 2. The method of claim 1, wherein the body lumen is thegastrointestinal tract.
 3. The method of claim 1, further comprising thestep of at least partially inverting the sleeve within the fillingcatheter.
 4. The method of claim 1, further comprising the step ofsealing the distal end of the sleeve.
 5. The method of claim 4, whereinsealing the distal end of the sleeve comprises attaching a graspingmember to the distal end of the inverted sleeve.
 6. The method of claim5, further comprising the step of actuating the grasping member distallyto promote eversion of the sleeve.
 7. The method of claim 5, wherein thegrasping member is a loop snare.
 8. The method of claim 5, wherein thedistal end of the inverted sleeve comprises a plurality of tailelements.
 9. The method of claim 5, wherein flowing the inflation mediawithin the sleeve to evert the sleeve is accomplished at a pressure ofless than about 3 psi.
 10. The method of claim 1, further comprisingsteering the filling catheter within the body lumen using one or morepull wires operably attached to the filling catheter.